BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ONE USE HOLDER

    MDR report key: 9526729 · Received December 27, 2019

    Report

    Report Number
    1917413-2019-02573
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    November 20, 2019
    Report Date
    March 20, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903648158
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR SHARP EDGE AT THE BASE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND SHARP EDGE AT THE BASE WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE IT IS DISCOVERED THAT THE HOLDERS HAVE SHARP PROTRUSIONS WITH A BD VACUTAINER® ONE USE HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE¿VE BEEN HAVING ISSUES WITH OUR ONE TIME USE TUBE HOLDERS. SOME OF THEM HAVE A SHARP PIECE ON THE EDGE AT THE BASE OF THE HOLDER, AND WHEN THE GIRLS GO TO GRIP IT WHEN THEY CHANGE A TUBE, IT PICKS AT THEIR FINGER, EVEN THROUGH THEIR GLOVES. IT HAPPENS A FEW TIMES A DAY, THEY PICK THEIR FINGER AS THEY ARE GRIPPING IT TO CHANGE A TUBE, NOT BREAKING THE SKIN, THOUGH. I CHECKED THROUGH A BIN OF THEM, I FOUND 17 OUT OF 71 HOLDERS HAD A SHARP EDGE TO THEM. THE LOT NUMBERS THAT SEEM TO BE AFFECTED ARE 9155957 AND 9240683. · WAS THERE ANY ALLEGED INJURY OR HARM TO USER OR PATIENT? NONE REPORTED.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9155957. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 2019-06-04. MEDICAL DEVICE LOT #: 9240683. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 2019-08-28. " A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IT IS DISCOVERED THAT THE HOLDERS HAVE SHARP PROTRUSIONS WITH A BD VACUTAINER® ONE USE HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE¿VE BEEN HAVING ISSUES WITH OUR ONE TIME USE TUBE HOLDERS. SOME OF THEM HAVE A SHARP PIECE ON THE EDGE AT THE BASE OF THE HOLDER, AND WHEN THE GIRLS GO TO GRIP IT WHEN THEY CHANGE A TUBE, IT PICKS AT THEIR FINGER, EVEN THROUGH THEIR GLOVES. IT HAPPENS A FEW TIMES A DAY, THEY PICK THEIR FINGER AS THEY ARE GRIPPING IT TO CHANGE A TUBE, NOT BREAKING THE SKIN, THOUGH. I CHECKED THROUGH A BIN OF THEM, I FOUND 17 OUT OF 71 HOLDERS HAD A SHARP EDGE TO THEM. THE LOT NUMBERS THAT SEEM TO BE AFFECTED ARE 9155957 AND 9240683. WAS THERE ANY ALLEGED INJURY OR HARM TO USER OR PATIENT? NONE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322799 BD VACUTAINER® ONE USE HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 364815 SEE H.10 50382903648158

    Patients

    Seq Age Sex Outcome Treatment
    1 Other